HIV InfectionsPhase 2NCT00158535
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection
A Phase 2 study testing liver transplantation in people with HIV Infections and Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the two-year survival after transplantation, the interaction between HCV and HIV after transplantation, the influence of HIV on HCV recurrence after transplantation, the interaction between immunosuppressive and antiretroviral… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- HIV Infections, Hepatitis C
- What is being tested?
- liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2002to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coinfection HIV-HVC
- Indication of liver transplantation for severe hepatopathy with life threatening:repetitive ascitis or infection of ascitis or icterus or decreased of prothrombin index under 50 percent or digestive haemorrhage by portal hypertension uncontrolled
Who cannot join
- Toxicomania
- Alcohol consumer (over 30g per day)
- AgHBs positive
- hepatocarcinoma over 5 cm or 3 nodules
- CD4 below 200/mm3
- Viral load below 400 cp
- HIV stade C
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hepato biliaire hopital paul Brousse
Villejuif, 94804 cedex
About this study
Official title: Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic
To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the two-year survival after transplantation, the interaction between HCV and HIV after transplantation, the influence of HIV on HCV recurrence after transplantation, the interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases, immunological follow-up and quality of life of these patients
Read the detailed description
Until recently, HIV infection was considered as a contraindication for liver transplantation. A dramatic improvement in survival of HIV patients have been observed since the advent of new antiviral treatments against HIV including antiproteases. However an important proportion of patients with HCV-HIV coinfection are suffering from life-threatening liver disease due to HCV infection. Liver transplantation may be considered in this particular group of patients.
The ideal timing for the indication of liver transplantation during HIV disease and during the course of HCV liver disease needs to be defined. Liver transplantation in this particular group of patients raised several questions : a) the role of HIV infection on prevalence and severity of HCV recurrence after transplantation ; b) the role of liver transplantation and immunosuppression on HIV disease ; c) drug interactions between immunosuppressive agents and antiproteases ; d) immunological follow-up and quality of life of these patients.
- Conditions
- HIV Infections, Hepatitis C
- Being tested
- liver transplantation
- Keywords
- Liver Transplantation, Hepatitis C, HIV Infections
- Medical subject headings
- HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.
Secondary outcomes (6)
Graft survival
Unexpected infections or neoplasia
Toxicity of antiretroviral and immunosuppressive treatments
Replicative kinetics of HIV and HVC after transplantation in blood and liver
Immune status of HIV and HVC
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2002
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Didier Samuel, MD, Principal investigator, Hopital Paul Brousse Villejuif FranceBruno Fallisard, MD, Study chair, Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158535
- Sponsor's protocol ID
- ANRS HC08 THEVIC
- Status last verified
- Jun 2026
- First submitted
- 9 Sep 2005
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Samri A, Roque-Afonso AM, Beran O, Tateo M, Teicher E, Feray C, Sebagh M, Guettier C, Dussaix E, Vittecoq D, Samuel D, Autran B, Duclos-Vallee JC. Preservation of immune function and anti-hepatitis C virus (HCV) immune responses after liver transplantation in HIV-HCV coinfected patients (ANRS-HC08 "THEVIC" trial). J Hepatol. 2009 Dec;51(6):1000-9. doi: 10.1016/j.jhep.2009.06.031. Epub 2009 Sep 12.
PubMed 19833404
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic
- ClinicalTrials.gov ID
- NCT00158535
- Acronym / sponsor ID
- ANRS HC08 THEVIC
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- Liver Transplantation, Hepatitis C, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Jun 2002
- Study completion
- Dec 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the two-year survival after transplantation, the interaction between HCV and HIV after transplantation, the influence of HIV on HCV recurrence after transplantation, the interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases, immunological follow-up and quality of life of these patients
Detailed description
Until recently, HIV infection was considered as a contraindication for liver transplantation. A dramatic improvement in survival of HIV patients have been observed since the advent of new antiviral treatments against HIV including antiproteases. However an important proportion of patients with HCV-HIV coinfection are suffering from life-threatening liver disease due to HCV infection. Liver transplantation may be considered in this particular group of patients.
The ideal timing for the indication of liver transplantation during HIV disease and during the course of HCV liver disease needs to be defined. Liver transplantation in this particular group of patients raised several questions : a) the role of HIV infection on prevalence and severity of HCV recurrence after transplantation ; b) the role of liver transplantation and immunosuppression on HIV disease ; c) drug interactions between immunosuppressive agents and antiproteases ; d) immunological follow-up and quality of life of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coinfection HIV-HVC
- Indication of liver transplantation for severe hepatopathy with life threatening:repetitive ascitis or infection of ascitis or icterus or decreased of prothrombin index under 50 percent or digestive haemorrhage by portal hypertension uncontrolled
Key exclusion criteria (7 listed)
- Toxicomania
- Alcohol consumer (over 30g per day)
- AgHBs positive
- hepatocarcinoma over 5 cm or 3 nodules
- CD4 below 200/mm3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver transplantation | Procedure or surgery | – |
Primary outcome
Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.
6 secondary outcomes
Graft survival
Unexpected infections or neoplasia
Toxicity of antiretroviral and immunosuppressive treatments
Replicative kinetics of HIV and HVC after transplantation in blood and liver
Immune status of HIV and HVC
Quality of life
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 19833404Samri A, Roque-Afonso AM, Beran O, Tateo M, Teicher E, Feray C, Sebagh M, Guettier C, Dussaix E, Vittecoq D, Samuel D, Autran B, Duclos-Vallee JC. Preservation of immune function and anti-hepatitis C virus (HCV) immune responses after liver transplantation in HIV-HCV coinfected patients (ANRS-HC08 "THEVIC" trial). J Hepatol. 2009 Dec;51(6):1000-9. doi: 10.1016/j.jhep.2009.06.031. Epub 2009 Sep 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Samuel, MD principal investigator
Hopital Paul Brousse Villejuif France
Bruno Fallisard, MD study chair
Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liver transplantation in people with HIV Infections and Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00158535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.